Small Arteriovenous Anastomosis in Fistula Creation: Establishing a Functional Vascular Access while Minimizing Steal Syndrome.

BACKGROUND: The size selection of the arteriovenous (AV) anastomosis in dialysis access creation requires a careful balance: the diameter must be large enough to accommodate sufficient flow for hemodialysis but small enough to minimize the complication of steal syndrome. Steal syndrome affects up to 10% of patients after creation of dialysis access with sometimes devastating consequences. Conventional teaching recommends a 7-10 mm anastomosis. We sought to assess the efficacy of using a smaller (5-6 mm) anastomosis in new arteriovenous fistula (AVF) creation. METHODS: We conducted a comparative retrospective analysis of patients who underwent fistula creation with a small versus regular size anastomosis at any upper extremity anatomic site between March 2019 and October 2020 at our institution. Anatomic sites included radiocephalic, brachiocephalic, and brachiobasilic. All AV anastomoses were measured intraoperatively to be 5-6 mm in diameter for the small size groups and 8-10 mm for the regular size group. Endpoints included steal syndrome, functional patency, primary patency, and secondary patency. RESULTS: Out of 110 patients who underwent an AVF creation, 59.1% received a 5-6 mm anastomosis with a median follow-up time of 10 ± 6 months. Patients' demographics and comorbidities were relatively similar between the 2 groups except for a higher rate of hyperlipidemia (55.4% vs. 28.9%, P = 0.008) in the small size group. Patients in the small size group were more likely to undergo a radiocephalic fistula (40% vs. 4.5%, P < 0.001) and to have a smaller mean vein diameter on preoperative duplex ultrasound (3.2±1 mm vs. 3.9±1 mm, P = 0.0016) when compared to their regular size counterparts. During follow-up, none of the patients in the small group developed steal syndrome (0% vs. 9%, P = 0.015). At 1 year, patients in the regular size group achieved higher rates of primary patency (67.9% vs. 46.9%, P = 0.02); however, no difference was seen in 1-year primary-assisted patency (84.9% vs. 73.6%, P = 0.3), secondary patency (89.6% vs. 79.5%, P = 0.3), or functional patency (87.7% vs. 82.2%, P = 0.64) between the small and regular size groups, respectively. CONCLUSIONS: The use of a 5-6 mm anastomosis in the creation of new AVFs of the upper extremities appears to be a technically safe option for dialysis access. Our experience suggests that smaller anastomosis still creates enough flow to maintain a functional AV access while minimizing the incidence of steal syndrome. Additionally, even with smaller vein sizes preoperative, adequate dialysis access can be created via a small sized anastomosis, including distal arm access. Larger studies with longer follow-up are needed to evaluate long-term outcomes of small anastomosis fistulas.

Novel Risk Score Calculator for Perioperative Mortality after EVAR with Incorporation of Anatomical Factors.

BACKGROUND: Hostile proximal aortic neck anatomy has been associated with an increased risk of perioperative mortality after endovascular aneurysm repair (EVAR). However, all available mortality risk prediction models after EVAR lack neck anatomic associations. The aim of this study is to develop a preoperative prediction model for perioperative mortality after EVAR incorporating important anatomic factors. METHODS: Data were obtained from the Vascular Quality Initiative database on all patients who underwent elective EVAR between January 2015 and December 2018. A stepwise multivariable logistic regression analysis was implemented to identify independent predictors and develop a risk calculator for perioperative mortality after EVAR. Internal validation was done using bootstrap of 1,000 reps. RESULTS: A total of 25,133 patients were included, of whom 1.1% (N = 271) died within 30 days or before discharge. Significant preoperative predictors of perioperative mortality were age (odds ratio [OR], 1.053; 95% confidence interval [CI], 1.050-1.056; P < 0.001), female sex (OR, 1.46; 95% CI, 1.38-1.54; P < 0.001), chronic kidney disease (OR, 1.65; 95% CI, 1.57-1.73; P < 0.001), chronic obstructive pulmonary disease (OR, 1.86; 95% CI, 1.77-1.94; P < 0.001), congestive heart failure (OR, 2.02; 95% CI, 1.91-2.13, P < 0.001), aneurysm diameter ≥ 6.5 cm (OR, 2.35; 95% CI, 2.24-2.47, P < 0.001), proximal neck length < 10 mm (OR, 1.96; 95% CI, 1.81-2.12; P < 0.001), proximal neck diameter ≥ 30 mm (OR, 1.41; 95% CI, 1.32-1.5; P < 0.001), infrarenal neck angulation ≥ 60° (OR, 1.27; 95% CI, 1.18-1.26; P < 0.001), and suprarenal neck angulation ≥ 60° (OR, 1.26; 95% CI, 1.16-1.37; P < 0.001). Significant protective factors included aspirin use (OR, 0.89; 95% CI, 0.85-0.93; P < 0.001) and statin intake (OR, 0.77; 95% CI, 0.73-0.81; P < 0.001). These predictors were incorporated to build an interactive risk calculator of perioperative mortality after EVAR (C-statistic = 0.749). CONCLUSIONS: This study provides a prediction model for mortality following EVAR that incorporates aortic neck features. The risk calculator can be used to weigh risk/benefit ratio when counseling patients preoperatively. Prospective use of this risk calculator may show its benefit in long-term prediction of adverse outcomes.

Prophylactic Perigraft Arterial Sac Embolization During EVAR: Minimizing Type II Endoleaks and Improving Sac Regression.

BACKGROUND: Type II endoleaks (ELII) are the most common complication following endovascular aneurysm repair (EVAR). Persistent ELII require continual surveillance and have been shown to increase the risk of Type I and III endoleaks, sac growth, need for intervention, conversion to open or even rupture, directly or indirectly. These are often difficult to treat following EVAR, and there are limited data regarding the effectiveness of prophylactic treatment of ELII. The aim of this study is to report the midterm outcomes of prophylactic perigraft arterial sac embolization (pPASE) performed in patients undergoing EVAR. METHODS: This is a comparison of 2 elective cohorts of those undergoing EVAR using the Ovation stent graft with and without prophylactic branch vessel and sac embolization. Patients who underwent pPASE at our institution had their data collected in a prospective, institutional review board-approved database. These were compared against the core lab-adjudicated data from the Ovation Investigational Device Exemption trial. Prophylactic PASE was performed at the time of EVAR with thrombin, contrast, and Gelfoam if the lumbar or mesenteric arteries were patent. Endpoints included freedom from ELII, reintervention, sac growth, all-cause mortality, and aneurysm-related mortality. RESULTS: Thirty-six patients (13.1%) underwent pPASE, while 238 patients (86.9%) had standard EVAR. Median follow-up was 56 months (33-60 months). The 4-year freedom from ELII estimates were 84% for the pPASE versus 50.7% for the standard EVAR group (P = 0.0002). All aneurysms in the pPASE group remained stable in size or demonstrated regression, whereas aneurysm sac expansion was seen in 10.9% of the standard EVAR group, P = 0.03. At 4 years, mean AAA diameter decreased by 11 mm (95% CI 8-15) in the pPASE group versus 5 mm (95% CI 4-6) for the standard EVAR group, P = 0.0005. There were no differences in the 4-year freedom from all-cause mortality and aneurysm-related mortality. However, the difference in reintervention for ELII trended toward significance (0.0% vs. 10.7%, P = 0.1). On multivariable analysis, pPASE was associated with a 76% reduction in ELII [(95% CI): 0.24 (0.08-0.65), P = 0.005]. CONCLUSIONS: These results suggest that pPASE in those undergoing EVAR is safe and effective in the prevention of ELII and significantly improves sac regression over standard EVAR while minimizing the need for reintervention.

Outcomes of elective peripheral endovascular interventions for peripheral arterial disease performed in hospital outpatient departments, ambulatory surgical centers and office-based labs.

BACKGROUND: A recent shift in the location where peripheral endovascular interventions (PVI) are performed has occurred, from traditional settings such as hospital outpatient departments (HOPD), to ambulatory surgical centers (ASC) and outpatient-based laboratories (OBL). Different settings may influence the safety and efficacy of the PVI, as well as how it is done. This study aims to compare the postprocedural outcomes and intraprocedural details between the three settings. METHODS: The Vascular Quality Initiative database was queried for all elective infrainguinal PVIs for occlusive peripheral arterial disease between January 2016 and December 2021. The primary outcomes were rates of postprocedural hospital admissions, postprocedural medical complications, and access site complications. Secondary outcomes included technical success and intraprocedural details, such as types and number of devices used, amount of contrast, and fluoroscopy time. The χ2 test, analysis of variance, and multivariate logistic regression were used to analyze the outcomes. RESULTS: A total of 66,101 PVI cases (HOPD, 57,062 [83.33%]; ASC, 4591 [6.95%]; OBL, 4448 [6.73%]) were included in the study. There were 445 cases requiring hospital admission (HOPD, 398 [0.70%]; ASC, 26 [0.57%]; OBL, 21 [0.47%]; P = .126). There were no significant differences in cardiac, pulmonary, or renal complications. Access site complications occurred in less than 1.7% of all cases and were significantly higher in OBLs when compared with ASCs (adjusted odds ratio [aOR], 3.70; 95% confidence interval [CI], 1.70-8.03; P = .001) and significantly lower in ASCs in comparison to HOPDs (aOR, 0.27; 95% CI, 0.18-0.41; P < .001). Technical success occurred in at least 92% of all cases, regardless of setting. There was a 16-fold increase in the use of atherectomy devices in an OBL vs HOPD setting (aOR, 16.79; 95% CI, 11.77-23.95; P < .001) and a five-fold increase in the use of atherectomy devices in an ASC vs HOPD setting (aOR, 5.37; 95% CI, 2.47-11.65; P < .001). There was a five-fold decrease in the use of special balloons in an OBL vs HOPD setting (aOR, 0.20; 95% CI, 0.10-0.39; P < .001) and a four-fold decrease when comparing ASCs with HOPDs (aOR, 0.25; 95% CI, 0.12-0.51; P < .001). CONCLUSIONS: Elective PVIs performed in any outpatient setting proved to be safe and technically successful. However, there are significant differences in the way PVIs are performed in each setting, such as the greater use of atherectomy devices in OBLs and greater use of special balloons in HOPDs. Long-term studies are needed to evaluate the durability and reintervention outcomes and understand factors associated with practice pattern variability across these different settings.

Revision of Aneurysmal Arteriovenous Access with Immediate Use Graft Is Safe and Avoids Prolonged Use of Tunneled Hemodialysis Catheters.

BACKGROUND: Aneurysmal arteriovenous fistulas (AVF) can pose a difficult treatment dilemma for the vascular surgeons. Prolonged tunneled dialysis catheters (TDCs) in patients requiring long-term dialysis are associated with significantly increased mortality compared to AVF. We aimed to elucidate the outcomes of aneurysmal arteriovenous (AV) access revision with aneurysm resection and Artegraft® (LeMaitre, New Brunswick, NJ) Collage Vascular Graft placement to avoid prolonged use of TDCs. METHODS: We reviewed all patients with aneurysmal AV access in whom the access was revised with aneurysm resection and jump graft placement at a single institution from 2018 to 2021. Outcomes were time to cannulation, reintervention rates, time to reintervention, and patency (primary, primary assisted, and secondary). Patency rates were estimated with Kaplan-Meier Survival analysis. RESULTS: A total of 51 revised aneurysmal AV accesses in 51 patients were studied, of which 23.5% (n = 12) had perioperative TDC placement. Three patients were done for emergent bleeding. The cohort was 62.8% male (n = 32) with a median age of 58 years (interquartile range: 49-67). Most patients had brachiocephalic AVF (n = 37 [72.6%]). The median follow-up time was 280 days. The median time to cannulation was 2 days. Time to cannulation was significantly longer in patients with perioperative TDC as compared with those without TDC (24 days vs. 2 days, P < 0.001). Reintervention was required in 41.2% of patients (n = 21), at median time of 47 days. At 30, 90, 180, and 365 days, primary patency rates were 84.3%, 78.3%, 66.6%, and 54.9%; primary assisted patency rates were 94.1%, 88.1%, 79.4%, and 79.4%; and secondary patency rates were 100%, 97.8%, 91.6%, and 91.6%, respectively. CONCLUSIONS: The revision of aneurysmal AV access (urgent or elective) with Artegraft as jump graft is safe, with acceptable short- and mid-term patency results. This allows dialysis patients to continue to have a functional access, decreasing the need for a tunneled catheter and reducing the associated risk of sepsis and increased mortality. This should be considered for all patients with aneurysmal, dysfunctional fistulas to maintain AV access and avoid TDC placement.

A Single Center Review of a Total Transfemoral Approach to Upper Extremity Access in Branched and Fenestrated Physician Modified Endografts.

BACKGROUND: Aortic aneurysms are normally treated by an endovascular approach. Due to the lack of devices and increasing experience, there is a growing number of complex aneurysms undergoing repair by physician modified endografts (PMEGs). Previously, our practice was to target visceral vessels exclusively through upper extremity access. We have since then shifted to an all transfemoral approach when possible. This study aims to show the operative benefits of transfemoral only approaches. METHODS: Patients who underwent a PMEG at a tertiary center between 2015 and 2020 were included. Patients were stratified into 2 groups based on branched vessel approach-transfemoral only versus axillary or composite (axillary and femoral). Forty-one patients had a pararenal or type IV thoracoabdominal aortic aneurysm (TAAA) and 15 patients had more complex TAAA. Primary outcomes were operative time, radiation exposure, fluoroscopy time, contrast, and blood loss. Secondary outcomes were 30-day mortality and major adverse events. Linear regression models were used to evaluate the association between approach type and the main outcomes. RESULTS: Fifty-six patients were included with 48% (n = 27) in the transfemoral group and 52% (n = 29) in the axillary/composite group. Baseline characteristics were similar between the groups. Intraoperative outcomes revealed significant increase in the average operative time (418 vs. 246 min, P < 0.001), in radiation exposure (2,755 vs. 1,740 mGy, P = 0.03), in fluoroscopy time (108 vs. 74 min, P = 0.01) and in blood loss (579 vs. 202 cc, P = 0.002) in the axillary/composite group compared to the transfemoral group. There was no significant difference in 30-day mortality or major adverse events including stroke. CONCLUSIONS: This study shows a transfemoral approach to complex endovascular aortic aneurysm repair as opposed to axillary/composite approach has decreased operative time, radiation exposure, and fluoroscopy time and no significant differences in 30-day mortality or major adverse events. When treating complex aneurysms, improving efficiency is important to minimize morbidity to patients and operators.

"Aortic Balloon Molding" during Ovation Endograft Implantation Expands Graft Use for Hostile Neck Anatomy.

BACKGROUND: Challenging aortoiliac anatomy such as short neck and narrow access vessels is responsible for endovascular repair of abdominal aortic aneurysm (EVAR) ineligibility in up to 50% of cases. The Ovation stent graft helped widen the range of abdominal aortic aneurysms (AAAs) suitable for EVAR thanks to its low-profile delivery system and polymer-filled sealing rings. However, its advantages are offset by a tight sizing chart that can lead to increased risk of type Ia endoleak or endograft infolding from under- or oversizing, respectively. We sought to assess the safety and efficacy of a novel endovascular technique developed to expand the use of the Ovation endograft while avoiding these issues. METHODS: We conducted a retrospective review of all patients who underwent EVAR with the Ovation endograft at our institution between March 2019 and December 2020. "Aortic Balloon Molding" or ABM is a novel endovascular technique in which the graft is pre-cannulated and a compliant aortic balloon is inflated at the site of the graft's sealing rings during polymer administration. The technique was preferentially performed in patients with hostile neck anatomy (HNA) defined as any or all of angulation >60°, reverse taper configuration, ≥50% circumferential thrombus, or calcification. Patients undergoing traditional deployment were compared to those in whom ABM was performed. End points included neck-related adjunctive procedures, technical success, type Ia endoleak at completion angiogram, and 1-year freedom from type Ia endoleak and migration. RESULTS: A total of 43 patients were included in the study, of which 26 (60.5%) were treated with the ABM technique. Mean follow-up was 7.9 ± 6 months. Patients in the ABM group were more likely to have a reverse taper neck (61.5% vs. 41.2%, P = 0.1), have significant circumferential thrombus or calcium (23.1% vs. 5.9%, P = 0.1), and be treated outside of the Ovation indications for use regarding anatomic characteristics (65.4% vs. 41.2%, P = 0.1). Technical success was achieved in 100% of cases. However, patients in the ABM group were less likely to require a neck-related adjunctive procedure (7.7% vs. 23.5%, P = 0.1). Only 1 type Ia endoleak was observed at completion angiogram in a patient treated without ABM. At 1 year, freedom from type Ia endoleak or migration was 100% for both groups. CONCLUSIONS: ABM proves to be a safe and effective adjunctive technique for the treatment of AAAs with HNA using the Ovation stent graft. This may allow optimal endograft sizing to achieve adequate seal in complex aortic anatomies. Further research is warranted to evaluate the long-term outcomes of this technique.

Long-term Outcomes Associated With Open vs Endovascular Abdominal Aortic Aneurysm Repair in a Medicare-Matched Database.

Importance: Endovascular aneurysm repair is associated with a significant reduction in perioperative mortality and morbidity compared with open aneurysm repair in the treatment of abdominal aortic aneurysm. However, this benefit decreases over time owing to increased reinterventions and late aneurysm rupture after endovascular repair. Objective: To compare long-term outcomes of endovascular vs open repair of abdominal aortic aneurysm. Design, Setting, and Participants: This multicenter retrospective cohort study used deidentified data with 6-year follow-up from the Medicare-matched Vascular Quality Initiative Vascular Implant Surveillance and Interventional Outcomes Network database. Patients undergoing first-time elective endovascular or open abdominal aortic aneurysm repair from 2003 to 2018 were propensity score matched. Patients with ruptured abdominal aortic aneurysm, concomitant procedures, or prior history of abdominal aortic aneurysm repair, were excluded. Data were analyzed from January 1, 2003, to December 31, 2018. Exposures: First-time elective endovascular or open repair for abdominal aortic aneurysm. Main Outcomes and Measures: The primary long-term outcome of interest was 6-year all-cause mortality, rupture, and reintervention. Secondary outcomes included 30-day mortality and perioperative complications. Results: Among a total of 32 760 patients (median [IQR] age, 75 [70-80] years; 25 706 [78.5%] men) who underwent surgical abdominal aortic aneurysm repair, 28 281 patients underwent endovascular repair and 4479 patients underwent open repair. After propensity score matching, there were 2852 patients in each group. Open repair was associated with significantly lower 6-year mortality compared with endovascular repair (548 deaths [35.6%] vs 608 deaths [41.2%]; hazard ratio [HR], 0.83; 95% CI, 0.74-0.94; P = .002), with increases in mortality starting from 1 to 2 years (84 deaths [4.3%] vs 126 deaths [6.7%]; HR, 0.63; 95% CI, 0.48-0.83; P = .001) and 2 to 6 years (211 deaths [25.8%] vs 241 deaths [30.6%]; HR, 0.73; 95% CI, 0.61-0.88; P = .001). Open repair, compared with endovascular repair, also was associated with significantly lower rates of 6-year rupture (117 participants [5.8%] vs 149 participants [8.3%]; HR, 0.76; 95% CI, 0.60-0.97; P < .001) and reintervention (190 participants [11.6%] vs 267 participants [16.0%]; HR, 0.67; 95% CI, 0.55-0.80; P < .001). Open repair was associated with significantly higher odds of 30-day mortality (OR, 3.56; 95% CI, 2.41-5.26; P < .001) and complications. Conclusions and Relevance: These findings suggest that overall mortality after elective abdominal aortic aneurysm repair was higher with endovascular repair than open repair despite reduced 30-day mortality and perioperative morbidity after endovascular repair. Endovascular repair additionally was associated with significantly higher rates of long-term rupture and reintervention. These findings emphasize the importance of careful patient selection and long-term follow-up surveillance for patients who undergo endovascular repair.

Contemporary Outcomes of Open Femoropopliteal Bypass by Autogenous Vein Graft in Infra-inguinal Arterial Occlusive Disease.

BACKGROUND: Although the majority of patients presenting with symptomatic peripheral arterial disease (PAD) are treated with the endovascular first approach, a significant number of these patients still require open bypass because of the extent of atherosclerotic burden or failure of the endovascular therapy. However, data available on the outcomes of femoropoliteal bypass in the contemporary era of PAD management is scarce. In this study, we evaluate realworld mid-term outcomes of femoropopliteal bypass for PAD. METHODS: We identified all patients who underwent open femoropopliteal revascularization with autogenous vein conduits for PAD at one institution between January 2012 and December 2017. Main endpoints included primary patency, amputation-free survival, overall survival, and limb salvage at 2 years. Outcomes were defined as per the Society for Vascular Surgery standards. Descriptive statistics were performed using univariable analyses including the mean and standard deviation for continuous variables and frequency and percentage for categorical variables. Event-free survival rates were estimated using Kaplan-Meier methods. RESULTS: There were 129 patients who received autogenous vein grafts. Median follow-up was 19 months (interquartile rangeIQR 11-26). Patients were predominantly male (59.7%), white (72.9%) with a mean age of 65 ± 11 years. The indications for surgery were disabling claudication in 36.4% of patients (n = 47) and chronic limb threatening ischemia (CLTI) in 63.6% (n = 82). Most patients had Trans-Atlantic Inter-Society Consensus C or D lesions (n = 81, 62.8%). Seventeen cases (16.3%) were redoing bypasses. Arm veins and spliced vein conduits were used in 12% and 7%, respectively. In 66% of procedures, the distal anastomosis was below the knee. Primary patency estimates at 6 months, 1 year and 2 years were 81.3%, 68.6% and 59.2%, respectively. Amputation-free survival rates were 93.4%, 88% and 82.1% at 6 months, 1 year and 2 years, respectively. Limb salvage rates among patients with CLTI were 93.4%, 90.4% and 87.2% at 6 months, 1 year and 2 years, respectively. Overall survival was 97.5%, 92.1% and 87.8% at 6 months, 1 year and 2 years, respectively. CONCLUSIONS: In this contemporary cohort of patients, femoropopliteal bypass showed lower patency than previously described. The fact that bypass surgery is performed on sicker patients with more extensive disease in the endovascular era might explain this discrepancy. However, our results demonstrated satisfactory patency and limb salvage rates and suggest that vein should always be used if available.

Outcomes of Endovascular-First Versus Bypass-First Approach for Patients With Chronic Limb-Threatening Ischemia Using a Medicare-Linked Database.

BACKGROUND: Chronic limb-threatening ischemia (CLTI) has been increasing in prevalence and remains a significant cause of limb loss and disability and a strong predictor of cardiovascular mortality. Previous studies have demonstrated that endovascular and open repair are similarly effective. These findings led to a significant increase in the adoption of the less-invasive endovascular-first (EVF) approach. However, it remains unknown whether the 2 treatment modalities have similar durability in today's real-world setting. The aim of the present study was to compare the midterm outcomes of the EVF and bypass-first (BF) strategies in patients with CLTI. METHODS: We identified all patients who had undergone limb revascularization from January 2010 to December 2016 in the Vascular Quality Initiative Medicare-linked database. Patients with a history of previous revascularization and those who had undergone hybrid or suprainguinal procedures were excluded from the present study. The remaining patients were divided into 2 groups: EVF and BF. The main end points were 2-year limb salvage, freedom from reintervention, amputation-free survival (AFS), and freedom from all-cause mortality (ACM). RESULTS: The EVF approach was applied to 12,062 patients (70%) and the BF approach to 5,166 patients (30%). The median follow-up was 33 months (interquartile range [IQR]: 14-49). Patients in the EVF group were older and had more comorbidities and tissue loss. At 2 years, the BF group had achieved greater rates of limb salvage (86.4% vs. 82.1%; P < 0.001), freedom from reintervention (72% vs. 68%; P < 0.001), AFS (66.9% vs. 56.3%; P < 0.001), and freedom from ACM (75.7% vs. 66.1%; P < 0.001). After adjusting for potential confounders, an effect of the treatment strategy on limb salvage (adjusted hazard ratio [aHR], 1.03; 95% confidence interval [CI], 0.93-1.16; P = 0.55), reintervention (aHR, 0.95; 95% CI, 0.89-1.019; P = 0.06), AFS (aHR, 0.94; 95% CI, 0.89-1.007; P = 0.08), and ACM (aHR, 0.93; 95% CI, 0.87-1.001; P = 0.055) was not observed. CONCLUSIONS: The present study is the largest real-word analysis showing the noninferiority of the EVF approach in patients with CLTI, with similar limb salvage, durability, AFS, and ACM compared with the BF approach. However, level 1 evidence on the role of the revascularization strategy in these challenging patients is needed.

Contemporary outcomes of limb-salvage procedures using Vascular Quality Initiative-Medicare-linked data: Racial and ethnic disparities persist.

BACKGROUND: Several reports have shown that ethnic and racial minority patients with chronic limb-threatening ischemia (CLTI) are more likely to undergo major amputation. Whether this disparity is driven by limited access to care, statistical discrimination, or biologic factors has remained a matter of debate. We studied the effects of race and ethnicity on the short- and long-term outcomes of limb-salvage procedures among patients with new-onset CLTI. METHODS: We identified all patients who had undergone first time (open or endovascular) revascularization for CLTI between January 2010 and December 2016 in the Vascular Quality Initiative-Medicare-linked database. These patients were divided into two groups: non-Hispanic White (NHW) and racial and ethnic minority (REM). The early end points included length of stay and operative mortality. The 2-year outcomes included major amputation, freedom from subsequent revascularization, number of limb salvage reinterventions, and all-cause mortality. Subanalyses comparing NHW and Hispanic patients and NHW and Black patients were also performed. RESULTS: Of 16,249 patients presenting with CLTI, 73.9% were NHW. The REM patients were younger (mean age, 69.9 ± 11.3 years vs 74.2 ± 10.5 years; P < .001) and more likely to be women (45.9% vs 37.7%; P < .001). Other baseline differences included a higher rate of smoking history, coronary artery disease, chronic obstructive pulmonary disease, and chronic kidney disease for the NHW group. In contrast, the REM patients were more likely to have diabetes and hypertension and were more likely to present with tissue loss (78% vs 76.6%; P = .04). The preoperative ankle brachial index and procedure type (endovascular vs open) were similar between the two groups. On multivariable analysis, the NHW group had had a 13% increase in the length of stay and a 25% decrease in operative mortality. Of the 2-year outcomes, the limb salvage estimate was 86% for the NHW group and 77.1% for the REM group (P < .001). A comparison between the two groups showed similar rates of freedom from subsequent revascularization (67.9% vs 67.1%; P =.2). The REM patients had had higher rates of overall survival (70.3% vs 68.4%; P = .01) compared with their NHW counterparts. The patients in the REM group were also more likely to have undergone more than two limb salvage reinterventions during follow-up (14.2% vs 8.6%; P < .001). After adjusting for potential confounders, the REM patients had significantly greater odds of major amputation at 2 years (adjusted hazard ratio, 1.49; 95% confidence interval, 1.36-1.63; P < .001). CONCLUSIONS: The results from the present Vascular Quality Initiative-Medicare-matched study have shown that REM patients continue to face a higher major amputation risk despite equivalent attempts at limb salvage. Further studies to identify the risk factors and evaluate intervention strategies that might be more effective in preventing amputation in this particular population are warranted.

The correlation of aortic neck length to late outcomes following EVAR with the Ovation stent graft.

OBJECTIVE: Endovascular aneurysm repair (EVAR) performed outside manufacturers' instructions for use due to short aortic neck for the treatment of abdominal aortic aneurysm (AAA) is associated with unfavorable outcomes. Newer endografts now have an indication for shorter neck aneurysms that previous endografts do not, but this cohort has yet to be evaluated individually. The aim of this study is to evaluate 5-year outcomes after EVAR in patients with short aortic necks (<10 mm) using the Ovation stent graft. METHODS: The study comprised 238 patients who underwent EVAR as part of the prospective international multicenter Ovation stent graft trials. The main inclusion criteria were AAA diameter ≥ 5 cm, proximal parallel neck length ≥7 mm, neck angulation ≤60°, and bilateral iliac fixation length ≥10 mm. A clinical events committee adjudicated adverse events through 1 year, an independent imaging core laboratory analyzed imaging through 5 years, and a data safety and monitoring board provided study oversight. Patients were divided into short neck (<10 mm) and standard neck (≥10 mm) groups. End points included long-term survival, freedom from aneurysm-related mortality (ARM), freedom from type Ia endoleak, and freedom from reintervention. RESULTS: Patients were predominantly male (81%) with a mean age of 73 ± 8 years. Median follow-up time was 58 months (interquartile range, 36-60 months). Of 238 patients, 41 (17.2%) had a proximal neck length <10 mm and would be considered outside the instructions for use with other stent grafts. Baseline characteristics were relatively similar between the two groups. The 5-year overall survival estimates were 77.8% for the standard neck group compared with 59.5% for the short neck group (P = .03). There were no differences in the 5-year freedom from ARM (99.2% vs 100%; P = .7), freedom from type Ia endoleak (96.3% vs 96.3%; P = .8), and freedom from reintervention (77.9% vs 79.7%; P = .7) between the standard and short neck groups, respectively. After adjusting for age and other potential confounders, short proximal neck was associated with a two-fold increase in 5-year all-cause mortality (adjusted hazard ratio, 2; 95% confidence interval, 1.02-3.8; P = .04]. CONCLUSIONS: The Ovation endograft performed well in short AAA neck with no difference in 5-year type Ia endoleak, reintervention, and ARM rates. However, short proximal neck was independently associated with a two-fold increase in the risk of all-cause mortality at 5 years. These findings confirm the prior literature on the association of hostile neck anatomy with late mortality following EVAR.

The Effect of Intravenous and Oral Beta-Blocker Use in Patients with Type B Thoracic Aortic Dissection.

BACKGROUND: Beta-blockers have become the cornerstone for medical management in patients with chronic type B aortic dissection (TBAD). However, the effect of being on and/or receiving intravenous beta-blockers during hospitalization on outcomes of surgical repair of TBAD is not fully described. We sought to investigate this association during open surgical repair (OSR) and endovascular (Endo) intervention for nontraumatic TBAD. METHODS: The Premier Healthcare Database was inquired (June/2009-March/2015). Patients with nontraumatic isolated TBAD were identified via ICD-9-CM diagnosis and procedural codes. Patients with codes that indicated TAAD were excluded. In-hospital mortality, cardiac complications (CHF, MI, arrythmia) and stroke were evaluated. Log binomial regression analyses with bootstrapping were performed to assess the relative risk of adverse outcomes. RESULTS: A total of 1,752 were admitted for OSR (54.3%) and Endo (45.7%) TBAD repair. Use of oral beta blocker (BB) was 16.0% in OSR and 56.4% in Endo groups. In each arm, patients on BB were more likely to be diabetic, on aspirin or statin and more likely to receive additional IV BB than nonBB patients. There was no significant difference in age, sex, race, or prior history of CHF between BB and nonBB groups. Mortality was proportionally lower in patients on BB in OSR group (7.9% vs. 16.7%; P = 0.006) and Endo (3.3% vs. 9.2%; P < 0.001). The adjusted relative risk for mortality and stroke were significantly lower in oral BB recipients compared with none [aRR (95% CI): 0.53 (0.32-0.90) and 0.46 (0.25-0.87); both P ≤ 0.02]. IV metoprolol was the only IV BB that reduced mortality [aRR (95% CI): 0.62 (0.46-0.85); P = 0.003]. A dose of ≤10 mg was associated with significant mortality reduction: 6.3% (3.0-9.5%) compared with 8.1% (4.6-11.6%) in no IV BB group. Cardiac complications were not affected by BB use. CONCLUSIONS: For patients with nontraumatic TBAD, use of oral BB was associated with significant protection against in-hospital mortality and stroke following repair. Metoprolol was the only Intravenous BB type associated with improved survival. Further research is warranted to elucidate the effect of beta-blockers on the long-term surgical outcomes of TBAD.

Association of abdominal aortic aneurysm diameter indexed to patient height with symptomatic presentation and mortality.

BACKGROUND: The current guidelines have recommended repair of abdominal aortic aneurysms (AAAs) according to the maximal AAA diameter and/or its growth rate. However, many studies have suggested that the AAA diameter alone is not sufficient to predict the risk of rupture or symptomatic presentation. Several investigators have attempted to relate the AAA diameter to the body surface area in predicting for rupture. However, these calculations have not resulted in conclusive evidence. We sought in the present analysis to introduce a novel diameter-to-height index (DHI) and test its utility in predicting for symptomatic presentations, including rupture and 30-day and 5-year mortality. METHODS: The Vascular Quality Initiative database (2003-2020) was used to identify patients who had undergone open or endovascular AAA repair. The DHI was defined as the AAA diameter in centimeters divided by the height in centimeters, yielding a score of 1 to 10. Multivariable logistic regression analysis was performed to assess the risk of symptomatic presentation, including rupture and 30-day mortality. Receiver operating characteristic curves were plotted, and survival analysis techniques were used to determine the hazard of 5-year mortality. RESULTS: A total of 64,595 patients were identified, of whom, 16.3% had presented with symptomatic AAAs, including rupture. Endovascular AAA repair was performed for 69.8% of the symptomatic AAAs and 84.3% of asymptomatic AAAs (P < .001). The symptomatic group were more likely to be women (24.6% vs 19.8%; P < .001) and Black (7.81% vs 4.44%; P < .001). The mean DHI was higher in the symptomatic group than in the asymptomatic group (mean DHI, 3.92 ± 1.1 vs 3.24 ± 0.7; P < .001). The adjusted odds of a symptomatic presentation increased with an increasing DHI (adjusted odds ratio [aOR], 1.70; 95% confidence interval [CI], 1.59-1.83; P < .001). Active smoking increased the risk of a symptomatic presentation (aOR, 1.38; 95% CI, 1.28-1.51; P < .001). However, the use of preoperative statins and beta-blockers significantly reduced the odds of a symptomatic presentation (aOR, 0.58; 95% CI, 0.53-0.64; P < .001; and aOR, 0.76; 95% CI, 0.69-0.84; P < .001), respectively. Compared with the AAA diameter, the receiver operating characteristic curve for the DHI to predict for symptomatic status was slightly, but significantly, higher (aOR, 0.702; 95% CI, 0.695-0.708; vs aOR, 0.695; 95% CI, 0.688-0.701; P < .001). The DHI increment was associated with a 1.08 greater odds of 30-day mortality (aOR, 1.08; 95% CI, 1.01-1.15; P < .001) for those with symptomatic AAAs. Similarly, the hazard of 5-year mortality was increased with an increasing DHI (adjusted hazard ratio, 1.20; 95% CI, 1.13-1.29; P < .001) only for those with asymptomatic AAAs. CONCLUSIONS: The DHI is a simple tool that could be more effective than the AAA diameter in predicting for symptomatic presentations. The DHI varied by sex and race, which could collectively help to provide an individualized prognosis. The DHI can additionally predict the 5-year mortality after AAA repair for those with asymptomatic AAAs only. However, the odds of 30-day mortality remained similar in both groups.

Polymer based endografts have improved rates of proximal aortic neck dilatation and migration.

BACKGROUND: Proximal aortic neck dilatation (PND) affects a considerable proportion of patients undergoing endovascular aneurysm repair (EVAR) and is associated with increased rates of type I endoleak (EL1), migration, and reinterventions. Although there are numerous studies investigating PND following the placement of endografts that utilize self-expanding stent (SES) technology, there are few reports for patients treated with endografts that utilize polymer-filled rings. The purpose of this study is to examine PND and graft migration after EVAR with the Ovation stent graft. METHODS: The study comprised patients who underwent EVAR as part of the prospective, international, multicenter Ovation stent graft trial. A clinical events committee adjudicated adverse events through 1 year, an independent imaging core laboratory analyzed imaging through 5 years, and a data safety and monitoring board provided study oversight. Neck diameter was measured at the level of the lowest renal artery. PND was defined as neck enlargement of 3 mm or more. Graft migration was defined as distal movement >10 mm or movement ≤10 mm when resulting in secondary intervention. RESULTS: A total of 238 patients received this device during the study period. Patients were predominantly male (81%), with a mean age of 73 ± 8 years. Median follow-up was 58 months (IQR 36-60). Almost half the patients (110 patients, 46%) had challenging anatomy; defined as outside the instructions for use (IFU) with other commercially available stent grafts. 41 patients (17.2%) had a proximal neck length <10 mm and 93 (39%) had a minimum access vessel diameter <6 mm. The technical success rate was 100%. The 1-, 3- and 5-year overall survival rates were 96.6%, 86.2% and 74.9%, respectively. The immediate postoperative proximal neck diameter ranged from 16 mm to 31 mm with a mean of 22.4 ± 3 mm. During follow-up, ten patients (4.2%) developed PND. Freedom from PND estimates at 1, 3 and 5 years were 97.7%, 96%, and 93.6%, respectively. None of the patients developed endograft migration. CONCLUSIONS: The use of the Ovation stent graft was associated with low rates of PND despite challenging neck anatomy in 17% of patients. No graft migration was observed. The design of this endograft may explain its superiority to SES in preventing neck dilatation and migration even in patients with challenging neck anatomy. This is important, as we continue to see significant late failures of EVAR due to proximal neck degeneration.

Favorable Outcomes in Octogenarians With Hostile Neck Undergoing Endovascular Repair Using EndoAnchors.

OBJECTIVES: Standard endovascular repair (EVAR) is not suitable in patients with hostile aortic anatomy. Open aneurysm repair (OAR) has been the gold-standard approach in managing these patients. EndoAnchors have been introduced as a technique to make EVAR in patients with short and angulated necks possible. The use of EndoAnchors in managing hostile aneurysms in octogenarians has not been studied before. Thus, the purpose of this study is to evaluate both short and long-term outcomes in octogenarians versus nonoctogenarians patients with hostile aortic anatomy undergoing EVAR using EndoAnchors. METHODS: Only patients enrolled in the primary arm of the ANCHOR registry were included and stratified into octogenarians (80-89 years) and nonoctogenarians (<80 years). Standard univariate (chi-square, fisher's exact, student's t-tests) and multivariable (logistic, cox-regression) analysis was used to evaluate patients' characteristics and outcomes between octogenarians versus nonoctogenarians as appropriate. RESULTS: Of 461 patients, 21% (N = 97) were octogenarians. Compared to nonoctogenarians, octogenarians were more likely to have a history of renal (32.0% vs. 18.4%) and genitourinary (30.9% vs. 21.2%) disease (both P < 0.05). They were also more likely to have an AAA diameter greater than 55 mm compared to nonoctogenarians (59% vs. 46%), had increased neck tortuosity index (mean [S.D.] 1.07 [0.08] vs. 1.05 [0.05]), greater proximal neck angulation (mean [S.D.]: 28.2 [17.3] vs. 23.7 [16] degrees) and were more likely to have localized (29.3% vs. 18.7%) and diffuse (25.6% vs. 20.7%) neck calcification (All P < 0.05). The overall procedural success was similar between both groups. However, octogenarians had higher rates of endoleaks at completion (32.0% vs. 21.2%, P = 0.03) and 30-day bleeding (12.4% vs. 5.8%) and cardiac (13.4% vs. 5.2%) complications (All P < 0.05). Additionally, compared to nonoctogenarians, octogenarians had lower freedom from all-cause mortality (87.90% vs. 96.50%) and type II endoleak (73.30% vs. 88.60%) based on Kaplan Meier estimates through one year (Both P < 0.05). In multivariable cox-regression analysis, octogenarians demonstrated a 5-fold increase in all cause mortality (HR [95% CI]: 5.19 [1.92-14], P = 0.001) and a 3-fold increase in type II endoleak (HR [95% CI]: 2.99 [1.54-5.81], P = 0.001) at 1-year. However, no significant difference was seen in aneurysm/device related mortality (HR [95% CI]: 1.42 [0.14-14.7], P = 0.77) and type I endoleak (HR [95% CI]: 1.71 [0.31-9.55], P = 0.54) at 1-year. CONCLUSIONS: Despite a worse aortic neck anatomy, octogenarians undergoing EVAR using EndoAnchors showed acceptable short and long-term outcomes. The results of our study could expand the utilization of EVAR in octogenarians with hostile neck.

Hospitalization Cost and In-hospital Outcomes Following Type B Thoracic Aortic Dissection Repair.

BACKGROUND: Several studies have reported lower mortality and morbidity after thoracic endovascular aortic repair (TEVAR) when compared to open surgical repair (OSR) in the treatment of type B aortic dissection (TbAD). However, there are few studies in the literature on the cost of both treatment options. Thus, the aim of this study is to focus on in-hospital outcomes and cost associated with TbAD repair procedures in a national database in the United States. METHODS: A retrospective review of the Premier Healthcare Database (PHD) between June 2009 and March 2015 was performed. ICD-9-CM codes were used to identify patients who underwent OSR or TEVAR for TbAD. Endpoints included in-hospital adverse events, in-hospital mortality and hospitalization cost. Logistic regression models and generalized linear models were used to assess the impact of treatment type on the main outcomes. RESULTS: Out of 1752 patients with TbAD, 54.3% underwent OSR and 45.7% underwent TEVAR. Patients in the TEVAR group were older [median age, 64 (IQR 54-73) vs. 59 (IQR 49-70), P < 1] and more likely to have preexisting comorbidities. IAE rates were 78.6% for the OSR group compared to 43.1% for the TEVAR group, P < 0.001. Patients in the OSR group showed significantly higher in-hospital mortality (15.3% vs. 5.9%, P < 0.001). After adjusting for potential confounders, OSR was associated with a 5-fold increase in IAE [aOR(95%CI): 4.8 (3.8-6.1), P < 0.001] and a 3-fold increase in in-hospital mortality [aOR(95%CI): 3.3 (2.1-5.1), P < 0.001]. In regards to charges related to the hospital stay, total cost was significantly higher among patients undergoing OSR $53,371 ($39,029-$80,471) vs. TEVAR $45,311 ($31,479-$67,960), P < 0.001. CONCLUSION: The present study shows that TEVAR presents an advantage in terms of morbidity, mortality and cost when compared to OSR in the treatment of TbAD. However, long-term cost-effectiveness of both procedures remains unknown. Further research is warranted to see whether the superiority of TEVAR is maintained over time.

Prophylactic Aneurysm Embolization during EVAR Is Safe, Improves Sac Regression and Decreases the Incidence of Type II Endoleak.

BACKGROUND: Clinically significant endoleaks remain costly, time-consuming, morbid and even mortal following endovascular aneurysm repair (EVAR). Perigraft arterial sac embolization (PASE) has been utilized to treat type II endoleaks (T2EL) diagnosed at the time of EVAR or after repair. Our objective was to analyze the safety and efficacy of prophylactic PASE on the incidence of T2EL and aneurysm sac regression in patients undergoing EVAR. METHODS: We performed a retrospective review of prospectively maintained databases from the University of California San Diego and the San Diego Veterans Affairs hospitals between 2015 and 2019. Prophylactic PASE (pPASE) was performed at the time of EVAR with thrombin, contrast and gelfoam liquid embolic aneurysm treatment as previously described. We evaluated technical success, freedom from T2EL, freedom from reintervention, from sac expansion, from type I/III EL, from all-cause mortality (ACM), from aneurysm-related mortality and from non-target embolization (NTE). RESULTS: A total of 44 patients were included in the study. Technical success was 100% and no NTE was observed. The average duration of follow-up was 14 ± 11months. In those treated and followed by CT scan, 100% of patients' aneurysms halted their growth following PASE, while 65.9% demonstrated sac regression. Mean aneurysm sac diameter decreased by 9 mm (95% CI 7-12). At 3 years, freedom from T2EL was 87.1%. Presence of T2EL did not result in aneurysm expansion during the follow-up period and thus did not require reintervention in any of these patients. Freedom from re-intervention was 83.2% for Type Ib EL and limb occlusion and all procedures were determined to be successful at the time of completion. No aneurysm-related deaths occurred during the follow-up. CONCLUSIONS: PASE proves to be an effective tool in sac management for prophylaxis of endoleak and maximizing sac regression in EVAR. It is safe, effective and durable when employed in this manner in the short and medium-term and was associated with low rates of T2ELs and reinterventions and a 100% freedom from sac expansion. Further analysis is required to evaluate the long-term outcomes of this adjunctive procedure in EVAR.

Increased mortality with paclitaxel-eluting stents is driven by lesion length.

BACKGROUND: Endovascular stenting has become the first-line treatment of symptomatic peripheral artery disease of the femoropopliteal axis (FPA). Several randomized clinical trials have reported that paclitaxel-eluting stents (PESs) significantly reduce the rates of restenosis. However, a meta-analysis investigating paclitaxel-coated devices in the FPA showed a significant increase in all-cause mortality after the use of PES. The aim of this study was to compare the long-term, real-world outcomes of bare-metal stents (BMSs) and PESs for treating FPA occlusive disease. METHODS: A retrospective review of the medical records of 296 patients who underwent FPA stenting between January 2011 and December 2017 was performed. Patients were grouped into BMS and PES groups. The primary end point was all-cause mortality. Secondary end points included limb salvage, primary patency, primary assisted patency, and secondary patency. A comparison between the two groups within TransAtlantic Inter-Society Consensus (TASC) II subgroups was also performed. RESULTS: Of the study cohort, 101 patients (34%) received PES, whereas 195 patients (66%) underwent BMS placement. Median follow-up time was 23 months (interquartile range, 7-40 months). The 2-year all-cause mortality estimates were 12% for the PES group compared with 11.4% for the BMS group (P = .26). There were no differences in the 2-year limb salvage (90.7% vs 92%; P = .4), primary patency (78.8% vs 81.1%; P = .62), primary assisted patency (100% vs 96.5%; P = .4), and secondary patency (100% vs 98.6%; P = .26) between the PES and the BMS groups, respectively (all P > .05). These findings persisted when patients were stratified by TASC II lesions. Among patients with TASC C and D lesions, the use of PES was associated with significantly higher 2-year all-cause mortality (23.9% vs 5.1%; P = .05). After adjustment for age and other potential confounders, PES use was associated with significant increase in all-cause mortality (adjusted hazard ratio, 2.3; 95% confidence interval, 1.31-27 P = .02) in TASC C and D patients. CONCLUSIONS: Consistent with the meta-analysis of several randomized clinical trials, the use of PES in a real-world setting was associated with a twofold increase in the risk of death. However, these findings were seen only among patients with TASC C and D lesions, who required multiple longer stents and potentially larger paclitaxel dose. There was no advantage in terms of patency in PES vs BMS in this population with extensive disease. Further studies of larger populations are required.

Practice patterns in the use of completion imaging after carotid endarterectomy.

BACKGROUND: The use of intraoperative completion imaging (completion carotid duplex ultrasound or angiography) to confirm the technical adequacy of carotid endarterectomy (CEA) remains a matter of controversy. The purpose of this study was to describe vascular surgeons' practice patterns in the use of completion imaging after CEA and to study the association between completion imaging and postoperative stroke/death and high-grade restenosis (>70%). METHODS: Patients who underwent CEA without concomitant procedures in the Vascular Quality Initiative database between 2003 and 2018 were included. Surgeons' practice patterns were defined on the basis of the distribution of completion imaging use among annual CEA cases per surgeon. Multivariable and Cox proportional hazards models were used to study the association between different practice patterns of completion imaging and perioperative and 1-year outcomes after CEA. RESULTS: Of 98,055 CEA cases, 26,716 (27.3%) were performed with completion imaging. Compared with cases in which completion imaging was not performed, completion imaging was associated with increased rates of immediate re-exploration (3.5% vs 0.9%; odds ratio [OR], 3.84; 95% confidence interval [CI], 2.74-5.38; P < .001), overall return to the operating room (RTOR; 1.6% vs 1.2%; OR, 1.24; 95% CI, 1.08-1.42; P < .01), and longer operative time (median [interquartile range], 105 minutes [82-132] vs 119 minutes [92-148]; P < .001). Of 1920 surgeons in our cohort, 45% never performed completion imaging, whereas 26% rarely performed completion imaging (for ≤20% of annual CEA cases), 9.5% performed it selectively (21%-79% of annual CEAs), and 19.6% used completion imaging routinely (≥80% of annual CEAs). Rarely performing completion imaging had higher rates of immediate re-exploration (6.5% vs 0.9%; OR, 7.2; 95% CI, 5.7-9.2; P < .001), in-hospital stroke (4.0% vs 1.1%; adjusted OR [aOR], 3.4; 95% CI, 2.6-4.6; P < .001), RTOR for bleeding (1.9% vs 0.9%; aOR, 2.1; 95% CI, 1.5-2.9; P < .001), and neurologic events (1.5% vs 0.4%; aOR, 3.6; 95% CI, 2.2-5.9; P < .001) compared with not performing completion imaging. It was also associated with increased stroke/death and repeated revascularization at 30 days and significant restenosis at 1 year. On the other hand, performance of selective and routine completion imaging was associated with increased immediate re-exploration (selective: aOR, 3.2 [95% CI, 1.9-5.5; P < .001]; routine: aOR, 3.7 [95% CI, 2.5-5.6; P < .001]) without any increase in in-hospital, 30-day, and 1-year adverse outcomes compared with cases performed without completion imaging. CONCLUSIONS: The performance of selective or routine completion imaging during CEA is safe and is not associated with increased adverse events compared with not using intraoperative completion imaging. However, rarely performing completion imaging is associated with a significant increase in the odds of perioperative stroke/death and RTOR, possibly because of unnecessary re-exploration for minor defects. The operator's experience and establishing a criterion for fixing residual defects are important to avoid unnecessary re-exploration.